510(k) Report

Devices descending from K953637

424 later devices reach CMS Accuprobe 550/530 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K251426da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+13K251817da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20251—
+13K252010SPY LaparoscopeStryker Endoscopy20250—
+13K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+13K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+13K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+13K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20220—
+13K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+13K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+13K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+13K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+13K212054Senhance Surgical SystemAsensus Surgical, Inc.20213—
+13K211325Senhance Surgical SystemAsensus Surgical, Inc.20210—
+13K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+14K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+14K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+14K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+14K230754L12 LED Light Source with AIMStryker20236—
+14K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+14K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+14K221611780 nm L11 LED Light Source with AIMStryker202210—
+14K220889Senhance Surgical SystemAsensus Surgical, Inc.20222—
+14K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+15K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—